Description

Review and evaluation of predictive performance
of human pharmacokinetics models using a large
cross-company database of diverse compound
properties.
The prediction of human pharmacokinetics based on in vivo, in vitro and physicochemical
properties has made signifi cant contribution to the rate of success
in advancing new medicines from discovery to the clinic. However, there is still
no industry consensus nor regulatory accepted best practices for predicting
human pharmacokinetics.
This workshop will bring together key stakeholders, including regulators, industry
scientists, academia, and leading experts to:
â€¢ Share the results of this unprecedented PhRMA initiative
â€¢ Present case examples of the impacts of prediction eff orts on candidate
selection, dose determination, drug interaction or toxicity risk assessment or
clinical planning
â€¢ Discuss best practices and issues or challenges to reaching consensus on
predictive eff orts associated with experimental design and data quality

Who Should Attend
Professionals from regulatory aff airs, industry, and academia who specialize in predictive models, drug development, clinical
research, and human pharmacokinetics or pharmacokinetic/pharmacodynamic models